Plain English Summary
Background and study aims
Osteoarthritis (OA), the most common type of arthritis, is a condition that causes joints to become painful and stiff. OA typically affects the knees, hips and small joints of the hands. OA is an incurable, long term condition but there are a number of treatments available to manage its symptoms, in addition to maintaining a healthy weight and regularly exercising. OA of the knee can often result in disability and make it hard for people to carry out their normal daily activities. It can also make it difficult for people to exercise. Physiotherapists can help people to create an exercise plan to manage their symptoms. They also provide various treatments to reduce pain and swelling in the joints. One such treatment is transcutaneous electrical nerve stimulation (TENS), which is often used to reduce pain in OA. In TENS, electrodes attached to a small, battery-operated machine are placed on the affected body part, such as the knee. When the machine is switched on, electrical signals are sent to the nerves which disrupt the pain signals. There are also various complementary and alternative therapies available to people with OA. Intrasound Therapy (IST) is a complementary therapy which uses sound waves to give pain relief for inflammatory conditions such as OA of the knee. It is a simple device for home use, and some OA sufferers have found that it helps relieve their symptoms. However, IST has not been scientifically tested so we don’t know how well it actually works. This is the first study to test how well IST works in adults with OA of the knee. The aim of this study is to see how well IST works to help patients with OA of the knee manage their pain compared to TENS.
Who can participate?
Adult with OA of the knee
What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (control group) carry out a range of exercises. Those in group 2 (intervention group) receive IST and carry out a range of exercises. Those in group 3 (intervention group) receive TENS and carry out a range of exercises. Mobility and pain levels are measured before treatment and after 8 weeks of treatment. Participants also complete questionnaires.
What are the possible benefits and risks of participating?
Participants are not exposed to any known risks as the treatments are considered safe to use.
Where is the study run from?
Lagos University Teaching Hospital (Nigeria)
When is the study starting and how long is it expected to run for?
June 2014 to November 2014
Who is funding the study?
Investigator initiated and funded (Nigeria)
Who is the main contact?
Dr A Aiyegbusi (scientific)
Dr Ayoola Aiyegbusi
Department of Physiotherapy
College of Medicine
University of Lagos
Intrasound therapy is an effective adjunct in the management of osteoarthritis of the knee: a preliminary clinical study
Will intrasound therapy be as effective as TENS, a proven physiotherapy modality as an adjunct in the management of osteoarthritis of the knee?
Health, Research and Ethics Committee of the Lagos University Teaching Hospital, Nigeria, 22/07/2014, ref: ADM/DCST/HREC/1806
Single-centre preliminary clinical interventional study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Mild/moderate unilateral osteoarthritis of the knee
1. Group 1 (control): closed kinetic chain exercises and range of motion exercises
2. Group 2 (intervention): intrasound therapy for 10 minutes followed by closed kinetic chain exercises and range of motion exercises
3. Group 3 (intervention): TENS for 15 minutes followed by closed kinetic chain exercises and range of motion exercises
Primary outcome measure
Assessed pre-treatment, at baseline and post-treatment after 8 weeks of intervention: Western Ontario and McMaster Universities (WOMAC) score to assess pain, stiffness and physical function.
Secondary outcome measures
Assessed pre-treatment, at baseline and post-treatment after 8 weeks of intervention:
1. 6-minute walk test
2. Range of motion of the knee
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Age 52-76
2. Unilateral OA of the knee
Target number of participants
Participant exclusion criteria
1. Patients with underlying systemic diseases and other rheumatic conditions of the knee
2. Patients with severe OA using the Kellgren and Lawrence system of classification
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Lagos University Teaching Hospital
Department of physiotherapy
Lagos University Teaching Hospital
Research & Ethics Committee
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Results to be disseminated through peer-reviewed scientific journals and presentation at scientific conferences
Intention to publish date
Participant level data
Available on request
Basic results (scientific)